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Lopinavir AND Ritonavir · Regulatory label update
U.S. Food and Drug Administration · July 23, 2026
An action by a regulator. Authoritative on labelling and availability.
This is an FDA supplemental approval for a labeling change to Kaletra (lopinavir/ritonavir) oral solution. The record documents a regulatory action but does not contain clinical trial results, efficacy data, or safety findings.
Regulatory label update.
This is an FDA supplemental approval for a labeling change to Kaletra (lopinavir/ritonavir) oral solution. The record documents a regulatory action but does not contain clinical trial results, efficacy data, or safety findings.
No safety signals, adverse event data, or comparative efficacy information is reported.
The source did not state who this applies to in practice.
FDA supplemental labeling approval for an established antiretroviral combination; regulatory action confirms labeling changes but does not report new clinical trial data or efficacy evidence.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Drugs@FDA record for application NDA021251. This is a regulatory action record, not a clinical study. Brand name: KALETRA. Active ingredient: LOPINAVIR AND RITONAVIR. Sponsor: ABBVIE. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-23. Products: KALETRA, SOLUTION, ORAL, LOPINAVIR 80MG/ML + RITONAVIR 20MG/ML.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.